Question: In patients with fully displaced midshaft clavicular fractures, how does elastic stable intramedullary nailing (ESIN) compare with nonoperative treatment?
Design: Randomized (allocation concealed)*, unblinded controlled trial with 2-year follow-up.
Setting: Emergency department of a university hospital in Innsbruck, Austria.
Patients: 68 patients between 18 and 65 years of age with a unilateral displaced midshaft clavicular fracture with no cortical contact between the main fragments. Exclusion criteria included fractures of the medial or lateral third of the clavicle, former injuries or additional pathological conditions affecting the function of the upper extremity, concomitant injuries, pathological or open fractures, fractures with an associated neurovascular injury, and contraindication for surgery with general anesthesia. 60 patients (88%) (mean age, 38 y; 87% men) completed the study.
Intervention: Patients were allocated to receive ESIN (n = 30) or nonoperative treatment (n = 30). Patients in the ESIN group underwent surgery with general anesthesia within 3 days after trauma. Surgery involved a 1 to 2-cm skin incision about 1 cm lateral to the sternoclavicular joint, and the anterior cortex was opened with a reamer. Closed reduction was done under fluoroscopic control; if closed reduction failed, direct manipulation of the fragments was done through an additional incision above the fracture site. 2.5-mm titanium endomedullary nails were used in men, and 2-mm nails were used in women. ESIN-group patients were offered a sling postoperatively but were encouraged to discard it as soon as possible. Implant removal was offered to all patients once fracture union was achieved. Patients in the nonoperative group received a shoulder sling and were encouraged to begin pain-dependent mobilization after 3 weeks and to discard the sling when pain subsided.
Main outcome measures: Outcomes were assessed with use of the Disabilities of the Arm, Shoulder and Hand (DASH) score (0 to 100; lower scores indicate better function) and the Constant Shoulder Score (higher scores indicate better function). Clavicular shortening determined by thorax posteroanterior radiographs and complications were also assessed.
Main results: DASH scores were significantly lower in the ESIN group during the first 18 weeks (p < 0.05), but no significant difference was observed between groups thereafter. The Constant Shoulder Score was higher in the ESIN group after 6 months. At 24 months, the mean Constant Shoulder Score in the ESIN group was higher than the score in the nonoperative group (Table). The greatest benefit was seen in type-B (wedge) and type-C (complex) fractures. The delayed union rate was lower in the ESIN group than in the nonoperative group (Table). There was no difference between groups for any other complications. Maintenance of clavicular length was improved in patients receiving ESIN (p < 0.05), with the greatest improvement in type-A (simple) fractures.
Conclusion: In patients with fully displaced midshaft clavicular fractures, elastic stable intramedullary nailing resulted in a lower rate of delayed union and better functional outcome than nonoperative treatment.
Although small, this well-designed, randomized, controlled trial by Smekal and colleagues is important for a number of reasons. First, the trial lends further support to the finding that the nonoperative treatment of completely displaced fractures of the clavicle can result in prolonged healing times (9 of 30 patients treated nonoperatively had a delayed union or nonunion)1. Second, as could reasonably be anticipated from similar experience with primary fixation of unstable fractures elsewhere in the body, early operative intervention dramatically improved outcome scores in the early postoperative time period (a 30-point improvement in DASH scores in the operative group at 4 weeks postoperatively). Third, although the clinical importance of the difference at the time of final follow-up could be debated (a mean 4-point superiority of the Constant Shoulder Score in the operative group at 2 years after injury), primary operative fixation led to a sustained improvement in shoulder outcome. Finally, this is the first prospective, randomized study that confirms the superiority of an intramedullary technique of fixation compared with nonoperative treatment.
The authors emphasize that operative fixation is reserved for healthy, active patients with completely displaced midshaft fractures of the clavicle. Concerns with their technique include backing out of the pin, which required "cutting back" under a local anesthetic in 7 patients; poor maintenance of length, especially in comminuted fractures; and pin bending or failure, a major concern in the physically larger patients.
While a larger, higher-quality study is needed, the only direct comparison between compression plating and intramedullary techniques has suggested some advantage to intramedullary Knowles pins2.
In conclusion, although the optimal surgical technique remains unclear, this study reinforces evidence that primary operative fixation is indicated for selected patients with displaced fractures of the clavicle.
Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am.2007;89:1-10.891
2007
Lee YS, Huang HL, Lo TY, Hsieh YF, Huang CR. Surgical treatment of midclavicular fractures: a prospective comparison of Knowles pinning and plate fixation. Int Orthop.2008;32:541-5.32541
2008
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